Yeah Zippy, according to the smallcapvoice interview, which was exactly 2 months ago, AMIC was suppose to file a 510(k) application within 60 days. Since the 60 days are up as of today, it would be safe to assume the 510(k) filing has been done. So if you tack on 90 days from today, that would put us at mid January. As I alluded to before, these things don't always go as planned, but ideally we should hear back from the FDA in the next 3 months. The 8K also mentions the caveat of funding, so we'll just have to wait and see. My expectation, and the 8K states, first qtr. of 2014. We probably won't get an individual statement on the 510(k) filing as a P.R., so #$%$ stated, best to call the company or wait for the 10Q next month. MDLAND~
My guess is as good as yours, but I have a hunch that they haven't yet filed the 510 (k). This is big news for a small cap like ADMD, and should be captured in a PR or conference call or SEC filing. The 60 days was due last week, so maybe we can hear something from the company or through SEC filing this week.
Resubmission or 510(k) filing? Good question either way. The 8K states under, " Why invest now?'', FDA form 510(k) for Y-90 RadioGel to be filed soon. FDA clearance anticipated first quarter of 2014.' But, as you and I know, these things don't always go as planned. I guess the first question, if you use the 8K as a reference, would be, when was the draft for the 8K written? Either way, it looks like we're a few months out. An update would be great, but we might not get much news, if any, before the 10Q, which is scheduled for mid November. MDLAND~